Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00
FDA device recall Z-0190-2012 · posted 2011-11-16 · Terminated
Recall details
- Recalling firm
- Isopure Corp
- Reason for recall
- The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).
- Action taken
- Isopure sent a Product Recall Notice dated October 24, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue the use of any Step 2 chemical from the affected product, place any remaining chemical into the original box, seal it with tape, and segregate the product to prevent it from being placed back into stock. The firm will pick up the product for return on a call tag. Customers would receive replacement product for all affected cases of the Step 2 chemical the firm received. For questions call 502-722-1000.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 91cs/12/4 oz plastic bottles
- Distribution
- Nationwide Distribution including the following states: AL, AZ, CA, FL, GA, IN, KS, LA, MA, MO, MS, NC, NH, NJ, NM, NV, OH, OR, PA, SC, TN, TX, and VA
- Date initiated
- 2011-10-24
- Date posted
- 2011-11-16
- Date terminated
- 2012-02-24
- Location
- Simpsonville, KY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES (K041163) | Isopure, Corp. | 2004-10-07 |